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Class 2 Device Recall iSTAT Level 2 Control |
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Date Initiated by Firm |
August 03, 2010 |
Date Posted |
February 02, 2011 |
Recall Status1 |
Terminated 3 on September 28, 2011 |
Recall Number |
Z-1020-2011 |
Recall Event ID |
56392 |
Product Classification |
Multi- analyte controls, all kinds (assayed) - Product Code JJY
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Product |
i-STAT Level 2 Control Value Assignment Sheets Human Consumption |
Code Information |
Abbott List Number: 06F13-01; Lot number B09342 - CLEW A20 artwork 726778-01A.pdf; Lot number B09154 - CLEW A20 artwork 726774-01A.pdf; Lot number B09342 - CLEW A18 artwork 726668-01A.pdf. Expiration: 11/2010. Abbott List Number: 025715, CLEW A20 Compact Disc containing value assignment sheets. |
Recalling Firm/ Manufacturer |
Abbott Point of Care Inc. 400 College Rd E Princeton NJ 08540-6607
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For Additional Information Contact |
Peter J. Scott 609-454-9000
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Manufacturer Reason for Recall |
Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types.
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FDA Determined Cause 2 |
Other |
Action |
Abbott Point of Care Inc., sent an URGENT RECALL NOTICE to all affected customers on 8/3/2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to replace all copies of the value sheets with the ones provided in the letter. ASLO, if they have a disc with the Value sheets on it, it is to be replaced with the updated disc and the original discarded. If the control materials, discs or value sheets have been forwarded to another facility, a copy of the letter was to be sent to them. The Business Reply card is to be completed and returned to Abbott. Questions or comments are to be directed to Abbott Point of Care Technical Support at 800-366-8020, Option 1. |
Quantity in Commerce |
8293 Value sheets worldwide |
Distribution |
Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of Argentina, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, El Salvador, France, Georgia Republic, Germany, Hong Kong, Israel, Italy, Kuwait, Mexico, Netherlands, New Zealand, Panama, Paraquay, Peru, Poland, South Africa, Sweden, Switzerland, Taiwan, Turkey, UAE, UK, Uruquay, and Yemen. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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